This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
As part of the new product introduction and product transfer activities, you will be supporting and leading validation activities for major projects at our Singapore site. You will ensure compliance to quality systems during validation activities and work closely with manufacturing and cross-functional teams. We value practical problem solvers who act with integrity, communicate clearly, and put patient safety first. This role offers clear career growth, hands-on impact on compliant supply, and a chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together.
Job Responsibility:
Provide QA oversight for validation projects covering equipment, utilities, facilities and computerized systems (including CSV lifecycle activities)
Lead the team on cleaning validation and process validation strategy
Author, review and approve validation plans, protocols, reports and related SOPs
Assess validation impact for changes, deviations and investigations
Act as QA approver for deviations, CAPAs, change controls and SOPs, ensuring timely, compliant closure
Approve engineering activities of validated equipment, utilities, facilities and computerized systems (e.g., calibration, preventive maintenance, alarm management)
Provide subject-matter expertise to cross-functional teams (Engineering, Operations, IT, Regulatory) on validation strategy and execution
Support in preparing validation documentation and responding to technical queries for product submission
Apply up-to-date knowledge of regulatory guidance (cGMP, 21 CFR Part 11, ICH) and ensure validation practices reflect industry best practice
Requirements:
Bachelor’s degree in science, engineering or a related discipline, or equivalent experience
Minimum 5 years’ experience in pharmaceutical quality assurance, validation or related roles
Practical knowledge of current Good Manufacturing Practice (cGMP) and regulatory requirements
Experience in authoring and approving validation documents and SOPs
Experience in assessing impact of changes, deviations and corrective actions on validation status
Strong communication skills with the ability to work effectively across stakeholders of different functions
Nice to have:
Experience with computerized system validation
Experience with method validation and pharmacopeia requirement
Prior role leading or involved in validation strategy for new product introduction or technical transfer projects
Project management experience and familiarity with continuous process verification approaches
Practical understanding of quality management systems and audit processes